NCT06477224

Brief Summary

This study is a randomized control trial exploring the therapeutic effects of scooter board activities on neck control and dysphagia in children with cerebral palsy (CP). Part of a Master of Science in Physical Therapy program, the research focuses on innovative uses of scooter boards-flat, wheeled platforms that allow children to propel themselves while lying or sitting. This activity is hypothesized to improve neck stability and swallowing functions, which are crucial for posture, movement, and reducing health risks such as malnutrition and aspiration pneumonia. The trial will employ validated tools like the Eating and Drinking Ability Classification System (EDACS), Schedule for Oral Motor Assessment (SOMA), and Gross Motor Function Measure (GMFM) to assess changes in participants. Conducted over six months at facilities including Rehab Care, Rich Care, and Royal College Hospital, it will involve 22 children, aged 6-10, diagnosed with spastic CP and exhibiting symptoms of dysphagia. The outcomes of this research could revolutionize therapeutic practices by providing a playful, engaging approach to therapy that enhances both motor and social skills.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 11, 2024

Last Update Submit

June 24, 2024

Conditions

Keywords

Cerebral Palsy (CP)DysphagiaNeck MusclesScooter Board ActivitiesPediatric Physical TherapyMotor Function

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function Measure (GMFM)

    The GMFM will help quantify the extent of improvement in neck control among participants, determining the effectiveness of the scooter board activities compared to routine physical therapy. This measure is crucial as effective neck control is fundamental for posture, movement, and various daily activities, thereby impacting the quality of life and functional independence of children with cerebral palsy. Total the scores from each category. The maximum possible score will depend on the number of categories included and the scoring range for each. A higher overall score generally indicates better oral motor functioning. Low scores in specific areas may indicate the need for targeted intervention.

    6 weeks

Study Arms (2)

Scooter Board Activities

EXPERIMENTAL

Participants in this arm receive treatment involving scooter board activities, which are hypothesized to improve neck control and alleviate symptoms of dysphagia.

Other: Scooter Board Activities

Routine Physical Therapy

EXPERIMENTAL

Participants in this arm receive conventional physical therapy treatments, which serve as the control group for comparing the effectiveness of the scooter board activities.

Other: Routine Physical Therapy

Interventions

Participants in this arm engage in scooter board activities designed to improve neck control and address dysphagia. These activities include moving the scooter board in various directions using their hands or feet, maneuvering through obstacle courses, and engaging in playful tasks that require reaching or turning, which can enhance neck muscle strength and stability.

Scooter Board Activities

Participants in this arm receive traditional physical therapy interventions, which might include range-of-motion exercises, muscle strengthening, stretching exercises, and postural control activities. These exercises are aimed at improving overall motor function, with a focus on neck stability and control. Standard physical therapy equipment such as therapy balls, balance boards, and resistance bands may also be used.

Routine Physical Therapy

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age: Participants must be between 6 to 10 years old.
  • Diagnosis: Must be diagnosed with spastic cerebral palsy.
  • Symptoms of Dysphagia: Must exhibit symptoms of dysphagia, as confirmed by clinical assessment.
  • Ability to Follow Instructions: Must be able to follow simple instructions to participate in the therapeutic activities effectively.

You may not qualify if:

  • Severe Cognitive or Sensory Impairments: Children with severe cognitive or sensory impairments that prevent participation in the intervention are excluded. This is to ensure that participants can engage effectively in the therapy sessions and follow the instructions required for the scooter board activities and assessments.
  • Previous Neck Muscle Strengthening Interventions: Children who have previously undergone specific interventions aimed at strengthening neck muscles are excluded to maintain a baseline uniformity among participants. This criterion helps in assessing the pure effect of the scooter board activities without interference from prior similar treatments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.

    PMID: 23346889BACKGROUND
  • Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.

    PMID: 27188686BACKGROUND
  • Benfer KA, Weir KA, Bell KL, Ware RS, Davies PSW, Boyd RN. Oropharyngeal Dysphagia and Cerebral Palsy. Pediatrics. 2017 Dec;140(6):e20170731. doi: 10.1542/peds.2017-0731.

    PMID: 29167377BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyDeglutition Disorders

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Arnab Altaf, PP-DPT

    Riphah International University Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It will be Randomized control trial in which Purposive sampling technique will be used. Two groups of 6-10 age will be formed in which participants will be randomly divided. Group A will only receives the experimental treatment, which in this case involves scooter board activities designed to improve neck control and potentially alleviate dysphagia symptoms and group B will receives conventional care, which typically involves standard physical therapy practices, serving as a baseline to evaluate the effects of the experimental treatment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 27, 2024

Study Start

June 1, 2024

Primary Completion

July 20, 2024

Study Completion

July 25, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share